TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced its operating and financial results for the first quarter 2015.

Operating Highlights
  • Announces Completion of GLP Studies
  • SurgiBot system FDA 510(k) Submission Expected in June 2015

"We are pleased with our progress in the first quarter and to have successfully completed our GLP studies, a key remaining step prior to our 510(k) submission," said Todd M. Pope, President and Chief Executive Officer of TransEnterix. "We are pleased to announce that we now anticipate being in a position to make our 510(k) submission for the SurgiBot system in June 2015."

For the three months ended March 31, 2015, the Company reported a net loss of $10.1 million, or $0.16 net loss per share, including research and development expenses of $7.5 million, sales and marketing expenses of $0.4 million, and general and administrative expenses of $2.0 million. Operating expenses were primarily associated with the development of the SurgiBot System. On March 31, 2015, the Company's cash and cash equivalents totaled $28.4 million.

At-The-Market Offering

On February 20, 2015, we entered into a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co., as sales agent, pursuant to which we can sell through Cantor, from time to time, up to $25 million in shares of common stock in an at-the-market offering. Through May 5, 2015, we have sold approximately 1.8 million shares with proceeds of approximately $5.7 million, net of commissions. All sales of shares have been and will continue to be made pursuant to an effective shelf registration statement on Form S-3 filed with the SEC.

Conference Call

TransEnterix, Inc. will host a conference call on Wednesday, May 6, 2015 at 8:30 AM ET to discuss its 2015 first quarter operating and financial results. To listen to the conference call on your telephone, please dial (888) 576-4387 for domestic callers or (719) 325-2361 for international callers approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company's website.

About SurgiBot

The  SurgiBot™ system, currently in development, is a minimally invasive, patient-side robotic surgery system. The system utilizes flexible instruments through articulating channels controlled directly by the surgeon, with robotic assistance, at the patient's bedside. The flexible nature of the system allows for multiple instruments to be introduced and deployed through a single incision. The SurgiBot system has not been cleared by the FDA for use in the United States.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery. The company is focused on the development and commercialization of the SurgiBot™ system, a minimally invasive surgical robotic system that allows the surgeon to be patient-side within the sterile field. For more information, visit the company's website at  www.transenterix.com .

Forward Looking Statements

This press release includes statements relating to the SurgiBot system, our flexible energy device and our current regulatory and commercialization plans for these products. These statements and other statements regarding our future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, whether the SurgiBot system's 510(k) application(s) will be submitted in June 2015 or cleared by the U.S. FDA, the pace of adoption of our products by surgeons, the success and market opportunity of our products, most notably the SurgiBot system, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with TransEnterix's business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 20, 2015, and other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
       

TransEnterix, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands)

(Unaudited)
 
Three Months Ended
March 31,
2015 2014
 
Sales $ _ $ 93
 
Operating Expenses
Cost of goods sold _ 220
Research and development 7,484 5,011
Sales and marketing 375 406
General and administrative   1,980   1,614
 
Total Operating Expenses   9,839   7,251
 
 
Operating Loss   (9,839 )   (7,158 )
 
 
Other Expense
Interest expense, net   (281 )   (321 )
 
 
Total Other Expense, net   (281 )   (321 )
 
 
Net Loss $ (10,120 ) $ (7,479 )
 
 
Other comprehensive income (loss)    
 
 
Comprehensive loss $ (10,120 ) $ (7,479 )
 
 
Net loss per share - basic and diluted $ (0.16 ) $ (0.15 )
 
 
Weighted average common shares outstanding - basic and diluted   63,745   48,850
     

TransEnterix, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)

(Unaudited)
 
March 31,2015 December 31,2014
 
Assets
Current Assets
Cash and cash equivalents $ 28,376 $ 34,766
Accounts receivable, net 53 133
Interest receivable 1 1
Other current assets   644   789
 
Total Current Assets   29,074   35,689
 
 
Restricted cash 250 250
Property and equipment, net 3,010 3,120
Intellectual property, net 2,116 2,241
Trade names, net 7 7
Goodwill 93,842 93,842
Other long term assets   52   62
 
Total Assets $ 128,351 $ 135,211
 
 
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable $ 2,278 $ 1,768
Accrued expenses 1,626 1,769
Note payable - current portion   1,540   610
 
Total Current Liabilities 5,444 4,147
 
Long Term Liabilities
Note payable - less current portion, net of debt discount   8,360   9,275
 
 
Total Liabilities 13,804 13,422
 
Commitments and Contingencies
 
Stockholders' Equity
Common stock $0.001 par value, 750,000,000 shares authorized at March 31, 2015 and December 31, 2014; and 64,478,085 and 63,182,806 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively 64 63
Additional paid-in capital 260,519 257,642
Accumulated deficit   (146,036 )   (135,916 )
 
 
Total Stockholders' Equity   114,547   121,789
 
 
Total Liabilities and Stockholders' Equity $ 128,351 $ 135,211
   

 

TransEnterix, Inc.

Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)
 
Three Months Ended
March 31,
2015     2014
Operating Activities
Net loss $ (10,120) $ (7,479)

Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:
Depreciation and amortization 390 286
Amortization of debt discount 15 -
Amortization of debt issuance costs 12 22
Stock-based compensation 899 405
Changes in operating assets and liabilities:
Accounts receivable 80 136
Interest receivable - (5)
Inventory - 50
Other current and long term assets 143 (178)
Restricted cash - 125
Accounts payable 510 54
Accrued expenses   (143)   125
Net cash and cash equivalents used in operating activities   (8,214)   (6,459)
 
Investing Activities
Proceeds from sale and maturities of investments - 1,722
Purchase of property and equipment   (155)   (187)
Net cash and cash equivalents used in investing activities   (155)   (1,535)
 
Financing Activities
Payment of debt - (938)
Proceeds from issuance of common stock, net of issuance costs 1,783 -
Proceeds from exercise of stock options   196   8
Net cash and cash equivalents provided by (used in) financing activities   1,979   (930)
Net decrease in cash and cash equivalents (6,390) (5,854)
Cash and Cash Equivalents, beginning of period   34,766   10,014
Cash and Cash Equivalents, end of period $ 28,376 $ 4,160
 
Supplemental Disclosure for Cash Flow Information
Interest paid $ 187 $ 179

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